Regulatory Affairs Pharmacist (Junior / Entry-Level)

Job Purpose

The Regulatory Affairs Pharmacist supports the company's regulatory activities to ensure compliance with Health Sciences Authority (HSA) requirements for medical devices. This role is suitable for fresh graduates or junior pharmacists, with training and guidance provided.

In addition to regulatory affairs duties, the pharmacist will assist in general company operations to support overall business functions.

Key Responsibilities

Regulatory Affairs (Primary Role)

• Assist in the preparation, submission, and maintenance of regulatory applications for medical device registration and licensing with HSA.
• Support compliance with applicable regulations, guidelines, and standards (e.g. Health Products Act, medical device regulations).
• Prepare and maintain regulatory documentation, including technical files, declarations, and supporting documents.
• Liaise with HSA and external stakeholders on regulatory matters under supervision.
• Track regulatory changes and assist in implementing updates to internal procedures.
• Support internal audits, regulatory inspections, and corrective actions when required.

Company Operations Support (Secondary Role)

• Assist with day-to-day company operations, including documentation and coordination with suppliers, customers, and service providers.
• Support inventory, order processing, logistics, and basic quality or compliance-related administrative tasks.
• Provide cross-functional support to management as needed to ensure smooth business operations.
• Training & Development and on-the-job training in regulatory affairs for medical devices will be provided.
• Exposure to end-to-end regulatory and operational processes within a medical device company.

Requirements

Mandatory

• Bachelor's degree in Pharmacy
• Eligible for or registered with the Singapore Pharmacy Council (SPC)

Preferred (but not required)

• Interest in regulatory affairs, compliance, or quality systems
• Basic understanding of medical devices or healthcare regulations
• Good attention to detail and documentation skills

Skills & Attributes

• Willingness to learn and take initiative
• Strong organisational and documentation skills
• Good communication skills (written and verbal)
• Able to work independently with guidance and supervision

Other Information

• This role is suitable for fresh graduates or pharmacists at an early stage of their career.
• Training will be provided; prior regulatory experience is not mandatory.
• Opportunity to gain hands-on exposure in both regulatory affairs and business operations within a growing medical device company.